Alphatec recalls Atec Insignia Anterior Cervical Plate System (REF 136-0358) due to potential screw mechanism disassociation post-surgery. Affected patients should contact for guidance.
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Alphatec is recalling a specific cervical plate system used in spinal surgery because the screw blocking mechanism might become loose after surgery. This could lead to complications if the plate shifts. Patients who received this model should contact the manufacturer for instructions.
The screw blocking mechanism in this cervical plate system could become disassociated or unlock after surgery. This might cause the plate to shift, potentially leading to complications if the bone structure is no longer properly aligned.
Patients who received the Atec Insignia Anterior Cervical Plate System (REF 136-0358) for spinal surgery are most at risk. The recall applies to those who had this specific surgical implant.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0358. This was sold as a prescription-only implant for spinal surgery.
Reach out to Alphatec Spine, Inc. for guidance on next steps after receiving the recalled product.
No, this recall specifically applies to the Atec Insignia Anterior Cervical Plate System (REF 136-0358) used in certain spinal surgeries.
Check for the product name 'Atec Insignia Anterior Cervical Plate System' with reference number 136-0358, which was sold as a prescription-only implant for spinal surgery.
Contact Alphatec Spine, Inc. for instructions on next steps.
We’ve drafted a message you can send Alphatec to request your refund or repair — edit it as you like.
Subject: Recall Z-1820-2021 — Alphatec Alphatec Hello, I own a Alphatec that is covered by recall Z-1820-2021 from Alphatec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
